Tobacco is among the most chemically complex substances known, with tobacco and tobacco smoke containing more than 8,000 compounds. While nicotine is regarded as the principal addictive component in tobacco, a variety of other factors also are believed to contribute to tobacco addiction. For example, tobacco smoke has been reported to have a monoamine oxidase (MAO) inhibitory effect. MAO is an enzyme involved in the breakdown of dopamine, which is a pleasure-enhancing neurotransmitter. See J. S. Fowler et al., “Inhibition of Monoamine Oxidase B in the Brain of Smokers,” Nature (Lond), 379(6567):733-736 (1996); J. Stephenson, “Clues Found to Tobacco Addiction,” Journal of the American Medical Association, 275(16): 1217-1218 (1996).
In addition to nicotine, tobacco also contains the minor alkaloids nornicotine, anabasine, and anatabine. High doses of tobacco alkaloids are known to cause disadvantageous side effects. Nicotinic alkaloids have been reported to cause nausea, dizziness, gastrointestinal distress, and palpitations in high doses. Goodman and Gilman, The Pharmacological Basis of Therapeutics, 11th Ed., pp. 232-233.
Yerba maté is a beverage common in South America where it is consumed for its stimulatory effects. Yerba maté is made from the stems and leaves of Ilex paraguarensis, a member of the Holly family, Aquifoliaceae. The mate beverage is usually prepared by one or more additions of boiling water to the dried plant material. The repeated additions of boiled water extract the stimulants from the plant. Numerous bioactive molecules are found in Yerba maté. Maté's stimulant affect has been attributed to methylxanthines released by the preparation process. Methylxanthines present in Yerba maté include caffeine, theobromine, theophylline and caffeoyl derivatives such as chlorogenic acid and caffeic acid. Caffeine is considered the principal stimulant. However, consumption of caffeine with other Yerba maté stimulants can give rise to undesirable side effects, commonly referred to as “xanthine toxicity,” which is characterized by palpitations, nausea, urinary dysfunction and visual disturbances. Goodman and Gilman, The Pharmacological Basis of Therapeutics, 11th Ed., pp. 728-729.
Nicotine replacement therapy (NRT) has become one of the most widely used techniques for treating smoking cessation. Some smoking cessation aids deliver nicotine via transdermal or transmucosal devices, which allow delivery of nicotine through the skin or mouth, respectively. U.S. Pat. No. 5,512,306 describes a smoking cessation aid in the form of an inclusion complex formed between nicotine and a cyclo compound such as polysaccharide. U.S. Pat. No. 5,525,351 discloses a saliva-soluble stimulant formed from a gel and nicotine.
Nicotine replacement therapy has had limited success in the treatment of cigarette addiction and as a means of reducing the level of consumption of cigarettes. Two of the significant disadvantages of NRT are, first, the therapy involves administering nicotine, a toxic and addictive substance. Second, many individuals who use tobacco, particularly smokers, experience an unpleasant taste (or “burn”) when ingesting nicotine orally. Smokers also experience similar effects from using smokeless tobacco products and, as a result, their use as an alternative to cigarettes has met with limited success. It would be desirable to develop a non-nicotine product that would avoid the addictive attributes of nicotine as well as the unpleasant taste associated with consumption of nicotine-containing products and which would provide temporary relief from the desire to smoke.